New Dosing Guidelines for Kids’ Liquid Medicines

New Dosing Guidelines for Kids’ Liquid Medicines

In an effort to make sure children take medications in proper doses, the FDA has issued final guidance to companies that make, distribute, and sell liquid over-the-counter drugs that are packaged with droppers, syringes, spoons, and cups.

May 5, 2011 -- In an effort to make sure children take medications in proper doses, the FDA has issued final guidance to companies that make, distribute, and sell liquid over-the-counter drugs that are packaged with droppers, syringes, spoons, and cups.

“Accidental medication overdose in young children is an increasingly common but preventable public health problem,” Karen Weiss, MD, program director of the FDA’s Center for Drug Evaluation and Research’s Safe Use Initiative, says in a news release.

Tips for Parents

The guidelines offer these tips to parents and caregivers of infants or young children:

The guidelines describe how clearly marked and easy-to-use dosage delivery devices can minimize the risk of unintentional overdose when children are treated with over-the-counter liquid medication for conditions such as cough, cold, pain, and digestion problems.

Improvements in Dosage Delivery Devices

The FDA says in a news release that the recommendations to companies include:

Dosage delivery devices for orally ingested liquid over-the-counter products should be included in all products.

Devices should be marked with calibrated units of liquid measurement, such as teaspoon, tablespoon, or milliliter, that are the same as specified in the product directions. The devices should have no unnecessary markings.

Manufacturers should make sure that dosage delivery devices are used only with products they are intended to be packaged with.

The liquid measure markings on the devices should be clearly visible and not obscured when the liquid product is added to the device.

People who have questions about dosage delivery devices or how to measure medicines should contact a doctor, pharmacist, or other health care professional. The FDA says health professionals and patients should report adverse events, side effects, or product quality problems to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.